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Medical Device Regulations, Registration, System and Clinical One-stop Service: 24x7 service hotline:+86-0571-86198618 Simplified Chinese English

SERVICE

Registration Service of Medical Devices

◆ CRC services ◆ Medical Device Business License ◆ Medical Device Registration ◆ Contract Research Organization ◆ ISO 13485 Quality System Certification ◆ GMP ◆ CE Certification Service ◆ FDA Registration (Filing) ◆ Software Integrity Verification Service ◆ Production process validation service ◆ ISO 15378 Medical Package System Certification ◆ ISO 13485 Internal Auditors Training ◆ Regulatory Services For Medical Devices
Information security service of medical

◆ ISO 27001 Information Security Certification ◆ ISO 20000 Information Service Certification ◆ Information system grade protection filing ◆ Business Continuity Management Services ◆ Internal Auditor Training
Medical Software Development

◆ Software of Good Supply Practice(GSP) ◆ Production System Development ◆ Customized software development

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ABOUT US

Hangzhou Zhengbiaoke Enterprise Management Co., Ltd.

Hangzhou Zhengbiaoke Medical Technology Consulting Co., Ltd. is located in Hangzhou, China. It is the third party of medical equipment professional services. To provide customers with one-stop service of medical device laws and regulations, operation, quality management system of medical device production, medical device registration, clinical, CRC, CE, FDA, medical information system customization and development, is one of the few institutions in Jiangsu, Zhejiang and Shanghai that have the whole process service capability of medical device.

MORE INFO

NEWS

Appendix Independent Software for Quality Management Standards of Medical Device Production The State has issued the Appendix Independent Software for Quality Management Standards of Medical Device Production (draft for comments).
Collective Decision-Making of Medical Device Registration Review Conclusion Collective Decision-making of Medical Device Registration Review ConclusionA new measure to reform the examination and approval system.
Clinical trials may be "life-saving straw" Cancer has become the number one killer in China, with 22% of new cancer cases and 27% of cancer deaths occurring in China.
Continuous Improvement of Standard System of Medical Devices in China Medical device standards are the technical norms followed by the research, production, operation, use and supervision and management of medical devices.